[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of January 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR173.340]
[Page 144.146]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 173 SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN
Subpart D Specific Usage Additives
Sec. 173.340 Defoaming agents.
Defoaming agents may be safely used in processing foods, in
accordance with the following conditions:
(a) They consist of one or more of the following:
(1) Substances generally recognized by qualified experts as safe in
food or covered by prior sanctions for the use prescribed by this
section.
(2) Substances listed in this paragraph (a)(2) of this section,
subject to any limitations imposed:
[[Page 145]]
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Substances Limitations
------------------------------------------------------------------------
Dimethylpolysiloxane (substantially 10 parts per million in food, or at
free from hydrolyzable chloride such level in a concentrated food
and alkoxy groups; no more than 18 that when prepared as directed on
percent loss in weight after the labels, the food in its ready-
heating 4 hours at 200 [deg]C; for-consumption state will have
viscosity 300 to 1,050 centistokes not more than 10 parts per million
at 25 [deg]C; refractive index except as follows: Zero in milk;
1.400.1.404 at 25 [deg]C). 110 parts per million in dry
gelatin dessert mixes labeled for
use whereby no more than 16 parts
per million is present in the
ready-to-serve dessert; 250 parts
per million in salt labeled for
cooking purposes, whereby no more
than 10 parts per million is
present in the cooked food.
Formaldehyde....................... As a preservative in defoaming
agents containing
dimethylpolysiloxane, in an amount
not exceeding 1.0 percent of the
dimethylpolysiloxane content.
[alpha]-Hydro-omega-hydroxy-poly For use as prescribed in Sec.
(oxyethylene)/poly(oxypropylene) 172.808(b)(3) of this chapter.
(minimum 15 moles)/
poly(oxyethylene) block copolymer
(CAS Reg. No. 9003.11-6) as
defined in Sec. 172.808(a)(3) of
this chapter.
Polyacrylic acid, sodium salt...... As a stabilizer and thickener in
defoaming agents containing
dimethylpolysiloxane in an amount
reasonably required to accomplish
the intended effect.
Polyethylene glycol................ As defined in Sec. 172.820 of
this chapter.
Polyoxyethylene 40 monostearate.... As defined in U.S.P. XVI.
Polysorbate 60..................... As defined in Sec. 172.836 of
this chapter.
Polysorbate 65..................... As defined in Sec. 172.838 of
this chapter.
Propylene glycol alginate.......... As defined in Sec. 172.858 of
this chapter.
Silicon dioxide.................... As defined in Sec. 172.480 of
this chapter.
Sorbitan monostearate.............. As defined in Sec. 172.842 of
this chapter.
White mineral oil: Conforming with As a component of defoaming agents
Sec. 172.878 of this chapter. for use in wash water for sliced
potatoes at a level not to exceed
0.008 percent of the wash water.
------------------------------------------------------------------------
(3) Substances listed in this paragraph (a)(3), provided they are
components of defoaming agents limited to use in processing beet sugar
and yeast, and subject to any limitations imposed:
------------------------------------------------------------------------
Substances Limitations
------------------------------------------------------------------------
Aluminum stearate...................... As defined in Sec. 172.863 of
this chapter.
Butyl stearate.........................
BHA.................................... As an antioxidant, not to
exceed 0.1 percent by weight
of defoamer.
BHT.................................... Do.
Calcium stearate....................... As defined in Sec. 172.863 of
this chapter.
Fatty acids............................ As defined in Sec. 172.860 of
this chapter.
Formaldehyde........................... As a preservative.
Hydroxylated lecithin.................. As defined in Sec. 172.814 of
this chapter.
Isopropyl alcohol......................
Magnesium stearate..................... As defined in Sec. 172.863 of
this chapter.
Mineral oil: Conforming with Sec. Not more than 150 p.p.m. in
172.878 of this chapter. yeast, measured as
hydrocarbons.
Odorless light petroleum hydrocarbons: ...............................
Conforming with Sec. 172.884 of this
chapter.
Petrolatum: Conforming with Sec. ...............................
172.880 of this chapter.
Petroleum wax: Conforming with Sec.
172.886 of this chapter.
Petroleum wax, synthetic...............
Polyethylene glycol (400)dioleate: As an emulsifier not to exceed
Conforming with Sec. 172.820(a)(2) 10 percent by weight of
of this chapter and providing the defoamer formulation.
oleic acid used in the production of
this substance complies with Sec.
172.860 or Sec. 172.862 of this
chapter.
Synthetic isoparaffinic petroleum
hydrocarbons: Conforming with Sec.
172.882 of this chapter.
Oleic acid derived from tall oil fatty Complying with Sec. 172.862
acids. of this chapter.
Oxystearin............................. As defined in Sec. 172.818 of
this chapter.
Polyoxyethylene (600) dioleate.........
Polyoxyethylene (600) monoricinoleate..
Polypropylene glycol................... Molecular weight range, 1,200-
3,000.
Polysorbate 80......................... As defined in Sec. 172.840 of
this chapter.
Potassium stearate..................... As defined in Sec. 172.863 of
this chapter.
Propylene glycol mono- and diesters of As defined in Sec. 172.856 of
fats and fatty acids. this chapter.
Soybean oil fatty acids, hydroxylated..
Tallow, hydrogenated, oxidized or
sulfated.
Tallow alcohol, hydrogenated...........
------------------------------------------------------------------------
[[Page 146]]
(4) The substances listed in this paragraph (a)(4), provided they
are components of defoaming agents limited to use in processing beet
sugar only, and subject to the limitations imposed:
------------------------------------------------------------------------
Substances Limitations
------------------------------------------------------------------------
n-Butoxypoly(oxyethylene)- Viscosity range, 4,850-5,350
poly(oxypropylene)glycol. Saybolt Universal Seconds
(SUS) at 37.8 [deg]C (100
[deg]F). The viscosity
range is determined by the
method ``Viscosity
Determination of n-
butoxypoly(oxyethylene)-
poly(oxypropylene) glycol''
dated April 26, 1995,
developed by Union Carbide
Corp., P.O. Box 670, Bound
Brook, NJ 08805, which is
incorporated by reference
in accordance with 5 U.S.C.
552(a) and 1 CFR part 51.
Copies of the material
incorporated by reference
are available from the
Division of Petition
Control, Center for Food
Safety and Applied
Nutrition (HFS-215), Food
and Drug Administration,
5100 Paint Branch Pkwy.,
College Park, MD 20740, and
may be examined at the
Center for Food Safety and
Applied Nutrition's
Library, 5100 Paint Branch
Pkwy., College Park, MD
20740, or at the National
Archives and Records
Administration (NARA). For
information on the
availability of this
material at NARA, call 202-
741-6030, or go to: http://
www.archives.gov/ federal--
register/ code-- of--
federal-- regulations/ ibr--
locations.html.
Monoester of alpha-hydro-omega-hydroxy- ............................
poly(oxyethylene) poly(oxypropylene)
poly(oxyethylene) (15 mole minimum)
blocked copolymer derived from low erucic
acid rapeseed oil.
------------------------------------------------------------------------
(b) They are added in an amount not in excess of that reasonably
required to inhibit foaming.
[42 FR 14526, Mar. 15, 1977, as amended at 43 FR 2872, Jan. 20, 1978; 46
FR 30493, June 9, 1981; 46 FR 57476, Nov. 24, 1981; 60 FR 54036, Oct.
19, 1995; 61 FR 632, Jan. 9, 1996; 63 FR 29134, May 28, 1998]
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